Vascular hole closure

ABSTRACT

A method and apparatus for closing a punctured blood vessel is described. The apparatus includes a suturing instrument adapted to apply at least one suture to at least a portion of a blood vessel in order to close a puncture wound therein. In a preferred embodiment, the suture is secured by crimping a sleeve member over the free ends of the suture with a crimping instrument.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. patent applicationSer. No. 09/041,207, filed on Mar. 12, 1998, which has been allowed,which is a continuation of U.S. patent application Ser. No. 08/734,159,filed on Oct. 21, 1996, now U.S. Pat. No. 5,766,183.

BACKGROUND OF THE INVENTION

[0002] The present disclosure relates to instruments and a method forclosing a hole or puncture in a blood vessel. More particularly, thisdisclosure relates to applying at least one suture to close a hole in ablood vessel after an intravascular catheterization procedure.

[0003] When performing catheterization procedures, such an angiographyor angioplasty, a catheter is generally introduced into the vascularsystem by first penetrating the skin, underlying muscle tissue and bloodvessel with a sharpened hollow needle. Next, a guide wire is commonlyinserted through the lumen of the hollow needle and is caused to enterthe selected blood vessel. Subsequently, the needle is typically slidoff the guide wire and a combination of a dilator and an introducer (oran introducer alone) are fed over the guide wire and pushed through theskin to enter the vessel. The guide wire can then be removed and thedesired catheter to carry out the procedure is fed through the lumen ofthe introducer and advanced through the vascular system until theworking end of the catheter is appropriately positioned. Following theconclusion of the catheterization procedure, the working catheter willbe withdrawn and, subsequently, the dilator and/or introducer will alsobe removed from the wound.

[0004] At this point in the procedure, the vessel leakage must becontrolled in order to stem the flow of blood through the puncture.Because it is common practice to administer a blood thinning agent tothe patient prior to many of the catheterization procedures, stemmingthe blood flow can be troublesome. A common method of sealing the woundis to maintain external pressure over the vessel until the puncturenaturally seals. This method of puncture closure typically takes aboutthirty minutes, with the length of time usually being greater if thepatient is hypertensive or anticoagulated. In some anti-congulatedpatients, the introducer is left in place for hours to allow theanti-coagulant to wear off. When human hand pressure is utilized, it canbe uncomfortable for the patient and can use costly professional time onthe part of the hospital staff. Other pressure techniques, such aspressure bandages, sandbags or clamps, have been employed, but thesedevices also require the patient to remain motionless for an extendedperiod of time and the patient must be closely monitored to ensure theireffectiveness.

[0005] Other devices have been disclosed which plug or otherwise providean obstruction in the area of the puncture. See, for example, U.S. Pat.Nos. 4,852,568 and 4,890,612, wherein a collagen plug is disposed in theblood vessel opening. When the plug is exposed to body fluids, it swellsto create a block for the wound in the vessel wall. A potential problemof plugs introduced into the vessel is that particles may break off andfloat downstream to the point where they may lodge in a smaller vessel,causing an infarct to occur. Collagen material also acts as a nidus forplatelet aggregation and, therefore, can cause intraluminal depositionof hemostatic agent, thereby creating the possibility of a thrombosis atthe puncture sight. Other plug-like devices are disclosed, for example,in U.S. Pat. Nos. 5,342,393, 5,370,660 and 5,411,520.

[0006] Surgical clips and clip appliers are known have also been used invascular surgery, particularly to join severed vessels. See, forexample, U.S. Pat. No. 4,929,240 (Kirsch, et al). The clips disclosed inthe '240 Patent are generally arcuate in shape and have two legs thatare biased towards each other by clip applier jaws to capture vesseltissue therebetween. While vascular clips have been successfully used insurgery, the surgical procedures in which the clips are typically usedallow the surgeon to view the area to be clipped. In catheter puncturerepair procedures, however, the wound is generally not visible, makingproper clip application, if attempted, difficult. Commonly assigned U.S.patent application Ser. No. 08/510,834 discloses the use of a guide wireto aid in locating the distal end of a clip applying device.

[0007] The use of suturing instruments to close a vessel puncture aredisclosed in U.S. Pat. No. 5,417,699 (Klein et al.), wherein one of theinstruments has a pair of needles, with the points oriented in aproximal direction, releasably disposed at a distal end thereof. Acannula is used to pass the distal end of the instrument and the needlesthrough a vessel puncture and into the vessel. Once in the vessel, thecannula is moved in a proximal direction to expose the needles.Thereafter, proximal movement of the instrument causes the needles topass through the vessel wall (from the inside to the outside) on eitherside of the vessel puncture and the needles are withdrawn. A strand ofsuture material secured between the blunt ends of the needles is alsodrawn through the needle puncture holes, thereby leaving a span ofsuture across the hole on the inside of the vessel. The suture can thenbe tied to close the vascular puncture. A disadvantage to this approachis the traumatic step of passing the cannula and distal end of thesuturing instrument through the vascular hole and then exposing sharpneedle tips within the vessel. Also, the instruments disclosed in the'699 Patent are relatively complex and may be unreliable in some vesselsand costly to manufacture.

[0008] Another suturing instrument is disclosed in U.S. Pat. No.5,431,666 (Sauer et al.). The Sauer '666 instrument uses a pair oflongitudinally movable needles to pick up corresponding ferrules at adistal end of the instrument. The ferrules have a strand of suturematerial disposed therebetween and are initially separated from theneedles by a gap in the instrument. In use, tissue to be sutured isdisposed in the gap between the needles and ferrules. A first needlepunctures the tissue, engages a ferrule and draws the ferrule backthrough the tissue. The instrument can then be relocated to anotherportion of tissue and the second needle is actuated to pick up and drawthe second ferrule therethrough. The suture material can then be tied orotherwise cinched in place to secure the tissue portions. When using thedevice disclosed in Sauer et al. '666, the surgeon is typically able toview the surgical site.

[0009] Therefore, there is a need for surgical techniques andinstrumentation suitable for dosing punctures in blood vessels,particularly those created during catheterization procedures. This needrequires a reliable hemeostasis of the puncture in a quick and efficientmanner with minimal trauma the surrounding vascular tissue.

[0010] The instrumentation must also allow the user to close thepuncture without directly viewing the punctured site.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Various embodiments of the surgical apparatus of the subjectapplication will be described herein below with reference to thedrawings, wherein:

[0012]FIG. 1 is a perspective view of the apparatus for suturing bodytissue;

[0013]FIG. 2 is an exploded perspective view of the surgical suturingapparatus of FIG. 1;

[0014]FIG. 3 is a cross-sectional view taken along lines 3-3 of FIG. 1showing the engagement of the second link and the proximal needle driverof the apparatus;

[0015]FIG. 3A is a cross-sectional view taken along lines 3A-3A of FIG.1 showing the engagement of the first link with the distal needledriver;

[0016]FIG. 4 is a side view, in partial cross-section, of the bodyportion illustrating the first and second levers in the initial (closed)position;

[0017]FIG. 4A is a side view, in partial cross-section, of the tubularportion corresponding to the position of the levers in FIG. 4 andillustrating the first needle prior to engagement with its respectiveferrule;

[0018]FIG. 4B is a top view, in partial cross-section, of the tubularportion corresponding to the position of the levers in FIG. 4 andillustrating both needles in the retracted position prior to engagementwith their respective ferrules;

[0019]FIG. 5 is a front view of the apparatus of FIG. 1 illustrating theconfiguration of the tongue;

[0020]FIG. 6 is a cross-sectional view taken along lines 6-6 of FIG. 4Aillustrating the engagement of the tongue and outer tube;

[0021]FIG. 7 is a cross-sectional view taken along lines 7-7 of FIG. 4A;

[0022]FIG. 8 is a cross-sectional view taken along lines 8-8 of FIG. 4Ashowing the engagement of the tongue with the face and the outer tube ofthe apparatus;

[0023]FIG. 9 is a view similar to FIG. 4 illustrating the second leverin the initial position and the first lever in the open position toadvance the first needle into engagement with the ferrule;

[0024]FIG. 9A is a view similar to FIG. 4B corresponding to the positionof the levers in FIG. 9 and illustrating the first needle engaged withthe ferrule and the second needle in the retracted position;

[0025]FIG. 10 is a view similar to FIG. 9A illustrating the first needlein the retracted position after engagement with the ferrule;

[0026]FIG. 11 is a view similar to FIG. 4 illustrating the first leverin the closed position and the second lever in the open position toadvance the second needle into engagement with the ferrule;

[0027]FIG. 11A is a view similar to FIG. 4B corresponding to theposition of the levers in FIG. 11 and illustrating advancement of thesecond needle into engagement with the ferrule;

[0028]FIG. 12 is a view similar to FIG. 4B illustrating the first andsecond needles in the retracted position after engagement with theirrespective ferrules;

[0029]FIG. 13 is a perspective view of the apparatus for crimping thesuture securing member;

[0030]FIG. 14 is an exploded perspective view of the apparatus of FIG.13;

[0031]FIG. 15 is a longitudinal cross-sectional view of the body portionof the apparatus of FIG. 13 illustrating the lever in the initial (open)position;

[0032]FIG. 16 is a longitudinal cross-sectional view of the tubularportion of the apparatus corresponding to the position of the lever inFIG. 15 and illustrating the jaws in the open position;

[0033]FIG. 17 is a cross-sectional view similar to FIG. 16 illustratingthe suture securing member being loaded into the tubular portion of theapparatus;

[0034]FIG. 18 is a cross-sectional view similar to FIG. 17 illustratingthe suture securing member loaded in the tubular portion of theapparatus;

[0035]FIG. 19 is a cross-sectional view similar to FIG. 15 illustratingthe lever in the closed position to close the jaws;

[0036]FIG. 20 is a cross-sectional view similar to FIG. 16 correspondingto the position of the lever in FIG. 19 and illustrating the jaws in theclosed position to crimp the suture securing member around a suture;

[0037]FIG. 21 is a cross-sectional view taken along lines 21-21 of FIG.16 showing the positioning of the suture tube;

[0038]FIG. 22 is a cross-sectional view taken along lines 22-22 of FIG.19 illustrating the engagement of the collar with the drive block of theapparatus;

[0039]FIG. 23 is a cross-sectional view similar to FIG. 20 showing thesuture securing member crimped on a suture and the apparatus beingwithdrawn from the surgical site;

[0040]FIG. 24 is a cross-sectional view of a blood vessel andsurrounding tissue illustrating a guide wire disposed within the bloodvessel;

[0041]FIG. 25 is a view similar to FIG. 24 illustrating a cannula andobturator assembly disposed over the guide wire;

[0042]FIG. 25A is an enlarged view of a portion of the obturatorassembly of FIG. 25 illustrating an aspiration port;

[0043]FIG. 26 is a cross-sectional view of a blood vessel andsurrounding tissue illustrating the surgical suturing apparatus of FIG.1 passing through a cannula and applying a suture adjacent the inferiorside of the vessel puncture wound;

[0044]FIG. 27 is a cross-sectional view of a blood vessel andsurrounding tissue illustrating the surgical suturing apparatus of FIG.1 passing through a cannula and applying a suture adjacent the superiorside of the vessel puncture wound;

[0045]FIG. 28 is a cross-sectional view of a blood vessel andsurrounding tissue with a suture applied across a puncture in the vesseland further illustrating the distal end of the suture securing device ofFIG. 13 with the suture passing therethrough;

[0046]FIG. 29 is similar to FIG. 28 with the suture securing devicepassing through the cannula and approaching the vessel puncture; and,

[0047]FIG. 30 is a surgical kit including a cannula and obturatorassembly, a suturing device and a suture securing device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] Referring now to the drawings, wherein like reference numeralsidentify similar or identical elements throughout the several views, anapparatus for applying a suture to body tissue is illustrated in FIGS.1-12 and is designated generally by reference numeral 10. Anotherapparatus is also disclosed, designated by reference numeral 200 andillustrated in FIGS. 13-23, for applying a connecting sleeve around thesuture after it has been applied to the body tissue by apparatus 10 inorder to secure the suture. Note that the terms first and “second” asused herein are for the reader's convenience and should not beinterpreted as necessarily denoting the order in which the componentsare actuated.

[0049] Turning first to the apparatus 10 for applying a suture, and withparticular reference to FIGS. 1 and 2, apparatus 10 includes a bodyportion 12 and an elongated tubular portion 14 extending from a distalend of the body portion 12. The tubular portion 14 includes a window 15configured to receive the body tissue to the sutured. Housed withintubular portion 14 are a pair of needles with are advanced by respectivelevers through the tissue positioned in window 15 and into engagementwith ferrules supported at the distal end of the apparatus. Each ferruleis attached to one end of a suture so that advancement of the needlesinto engagement with the ferrules effectively engages the suture.Subsequent retraction of the needles into the tubular body portion pullsthe suture through the body tissue. This is discussed in detail below.

[0050] Turning initially to the tubular portion 14, and with continuedreference to FIGS. 1 and 2, tubular portion 14 includes an outer tube 30having an axial bore 32 dimensioned to receive a proximal needle guide60 and a distal needle guide 50. Also mounted within outer tube 30, atthe distal portion 33, is a face 46 having a first opening 47a toreceive first needle 20 and a second opening 47 b to receive secondneedle 22. Openings 47 a and 47 b are in axial alignment withlongitudinal grooves 52 a, 52 b and 62 a, 62 b of needle guides 50 and60, respectively.

[0051] Extending from distal end portion 33 of outer tube 30 is a tongue36 on which mounts a ferrule holder 40. More specifically, tongue 36includes a base 37 terminating in a T-shaped extension 38 which extendsthrough a notch 55 in distal needle guide 50 and through a notch 34 inouter tube 30 (see also FIGS. 4A and 6) to fixedly mount tongue 36 toouter tube 30 and guide 50. Alternately, the tongue 36 can be brazed tothe outer tube. Face 46 is snapped onto base 37 in front of T-extension38. Ferrule holder 40 has projecting surfaces 41 which sit withincorrespondingly configured grooves within the tongue 36 as best seen inFIG. 4A. Lip 36 a, in conjunction with the projection and groovearrangement, functions to retain ferrule holder 40 on base 37 of tongue36. Tongue 36 also has a distal opening 39, axially aligned with thecentral bore 103 of body portion 12, to allow passage of guide wire tube82 to accommodate a guide wire (not shown in FIG. 2) in order to locatethe instrument for the reasons discussed below. Exit opening 39 a,formed at a bottom surface of tongue 36 as viewed in FIG. 4A, provides apassageway for radiopaque dye or other medium if injected through guidewire tube 82.

[0052] With reference to FIGS. 2, 4A and 12, ferrule holder 40 has apair of recesses to receive ferrules 70 and 72. These ferrules, asshown, are mounted to opposite ends of the suture 75, and have a centralopening dimensioned to frictionally engage sharp tips 21, 23 of needles20, 22. FIG. 4B shows needles 20, 22 prior to engagement where they areinitially spaced from ferrules 70, 72, with the distal tips 21, 23positioned in openings 47 a, 47 b of face 46.

[0053] When the first needle 20 is advanced by first lever 101 in themanner described below, needle 20 passes through opening 47 a andthrough the body tissue positioned in window 15 into the recess offerrule holder 46 so-that tip 21 frictionally engages ferrule 70 asillustrated in FIG. 9A. Subsequently, when needle 20 is retracted,ferrule 70 is likewise retracted into opening 47 a, pulling the portionof suture 75 through the body tissue as shown in FIG. 10. In a similarmanner, when needle 22 is advanced by second lever 102, it passesthrough opening 47 b in ferrule holder 46 and through the body tissue sothat tip 23 enters the recess of ferrule holder 46 to frictionallyengage ferrule 72 as shown in FIG. 11A. When subsequently retracted,needle 22 pulls ferrule 72 through opening 47 b in face 46 to pullsuture 75 through the body tissue as shown in FIG. 12.

[0054] Turning now to the body portion 12 of apparatus 10 which containsthe actuating mechanisms for driving the needles 20, 22, and withinitial reference to FIGS. 1 and 2, the body portion 12 includes firstand second levers 101, 102 pivotably mounted thereto. The first lever101 is operatively connected to first needle 20 by link 104 and thesecond lever 102 is operatively connected to the second needle 22 bylink 106. Lever 101 is seated in its initial position within cavity 180a of body portion 12 such that the bottom surface 101 a of the lever 101contacts the planar surface 181 inside the cavity 180 a as shown in FIG.3A. Lever 102 is similarly seated in a cavity 180 b (not shown in FIG.2) such that surface 102 a abuts planar surface 183 (see FIG. 3).

[0055] The first lever 101 is pivotably mounted to the distal end ofbody portion 12 by a lever mounting pin 110 extending through distalapertures 108 and through the illustrated openings in the body portion12. First link 104 is mounted to lever 101 by a link pin 114 extendingthrough apertures 112 in lever 101 and through the distal openings 116in link 104. The proximal end of link 104 is mounted to tab 154 ofdistal or first needle driver 150 by a link pin 118 extending throughproximal apertures 120 and tab opening 152 of needle driver 150.

[0056] Needle driver 150 functions to advance first needle 20 intoengagement with ferrule 70. Needle driver 50 is positioned in cavity 13b of body portion 12 and has a first longitudinal opening 153dimensioned to frictionally mount a proximal portion of first needle 20such that distal movement of needle driver 50 advances needle 20distally. Needle driver 50 also has a second longitudinal opening 155,dimensioned slightly larger than the first longitudinal opening 153 andthe diameter of the first needle 20, to allow unobstructed passage ofsecond needle 22 therethrough. Consequently, when lever 101 is pivotedfrom the initial (closed or prefired) position of FIG. 4 to the open(fired) position of FIG. 9, link 104 slides needle driver 150 distallyto the position shown in FIG. 9. Note that tab 154 will engageprojection 142 of stop 140 (positioned in recess 13 a of body portion12) to limit the distal travel of needle guide 150. As the needle driver150 is advanced distally, it carries the needle 20 out of the opening47A in face 46, through window 17 and into engagement with ferrule 70.After engagement of pointed tip 21 of needle 20 with ferrule 70, lever101 is returned to the initial position of FIG. 4 causing link 104 toslide the distal needle driver 150 back to its initial (proximal)position with the needle 20 retracting the ferrule 70 proximally intoface 46 of tubular portion 14.

[0057] The second lever 102, as shown in FIGS. 2, 4 and 9, functions ina similar manner to first lever 101 and is designed to advance secondneedle 22. Distal apertures 122 of lever 102 receive mounting pin 124 topivotably connect lever to body portion 12. Lever pin 128 connectssecond link 106 to lever 102 as it extends through apertures 126 inlever 102 and distal openings 130 in link 106. The proximal end ofsecond link 106 is connected to proximal or second needle driver 160 vialink pin 132 extending through proximal openings 134 in link 106,aperture 162 in tab 164 of needle driver 160, and through theillustrated openings in body portion 12.

[0058] Proximal needle driver 160 has an opening 163 dimensioned tofrictionally mount proximal portion of needle 22. When lever 102 ispivoted from its initial position of FIG. 4 away from body portion 12 tothe open position shown in FIG. 11, link 106 will advance proximalneedle driver 160 to cause distal advancement of needle 22 throughopening 47 b in face 46 to engage ferrule 72 (Note that the secondneedle 22 slides through first longitudinal opening 153 of distal needledriver 150 as discussed above). In this manner, as illustrated in FIG.11A, pointed tip 23 of needle 22 frictionally engages ferrule 72. Tab164 of needle driver 160 abuts projection 148 of stop 146 to limit itsdistal advancement which in turn limits the travel of needle 22. Whenlever 102 is returned to its initial position of FIG. 4, proximal needledriver 160 is retracted to its original position thereby retractingneedle 22 and ferrule 72 back into face 46 through opening 47 b.

[0059] End cap 170 is mounted on the proximal end of body portion 12 andhas recesses 172, 174 configured and dimensioned for receipt of theuser's finger to facilitate actuation of first and second levers 101,102. End cap 170 also includes first opening to allow passage of tube 80and a second opening to allow passage of tube 82.

[0060] Supported within tubular portion 14 and extending through axialbore 103 of body portion 12 and end cap 170, are suture tube 80 andguide wire tube 82. More specifically, tubes 80 and 82 extend throughaligned notches 51, 61 of distal and proximal needle guides 50, 60respectively (see e.g. FIGS. 4A and 7), through notch 156 in distalneedle driver 150 and through notch 165 of proximal needle driver 160.Tube 80 is designed to receive the suture 75 to retain it within theapparatus. Tube 82 is configured to receive a guide wire for locatingthe apparatus 10 during use as will be described below. Additionally,tube 82 can function to transport fluid, such as radiopaque dye, whichcan be ejected out of opening 36A in tongue 36 (see FIG. 4).

[0061] In use, in the initial position, levers 101 and 102 are seatedwithin the respective cavities 180 a, 180 b in the body portion 12 asshown in FIG. 4. In this position, links 104 and 106 are substantiallyparallel to the respective levers 101, 102 and the needle drivers 150,160 are in the proximal position. When it is desired to advance needle20 through the body tissue positioned in window 15, lever 101 is pivotedaway from body portion 12, thereby moving distal needle driver 150 to adistal position, limited by stop 140, to carry needle 20 distally.Consequently, needle 20 is guided along grooves 62 a, 52 a of needleguides 60, 50, exits through opening 47 a in face 46, and advancesthrough the body tissue into the ferrule holder 40 to engage ferrule 70as shown in FIG. 9A to pick up one end of suture 75. Lever 101 is thenreturned to its initial position of FIG. 4, sliding distal needle driver150 to its proximal position to retract the needle 20 and attachedferrule 70 inside face 46 to the position of FIG. 10, thereby pullingone end of suture 75 through the body tissue.

[0062] Subsequently, second lever 102 is pivoted away from body portion12 to the position of FIG. 11. This moves proximal needle driver 160 toa distal position to advance second needle 22. Second needle 22 isguided in grooves 62 b, 52 b of needle guides 60, 50, through opening 47b in face 46, and through the body tissue positioned in window 17 intoferrule holder 40 to engage ferrule 72 as shown in FIG. 11A to pick upthe other end of suture 75. Lever 102 is returned to the initialposition of FIG. 4 to slide proximal needle driver 160 to its originalposition to retract needle 20 and attached ferrule 72 inside face 46 asshown in FIG. 12. This pulls the second end of suture 75 through thebody tissue. It should be appreciated that lever 102 can be actuatedbefore lever 101 if desired.

[0063] Turning now to the apparatus 200 for securing the suture 75applied by apparatus 10, and with initial reference to FIGS. 13-16,apparatus 200 includes a cylindrical body portion 212 and a tubularportion 210 extending from a distal end of the body portion 212 andhousing jaw assembly 218 for crimping a suture securing member orconnecting sleeve 216 held in the jaws. A lever 214 is pivotably mountedto the body portion 212 and is movable from the initial (open) positionillustrated in FIGS. 13 and 15 to a closed position illustrated in FIG.19 to cam the jaws to a closed position to crimp the suture securingmember 216 in the manner described below.

[0064] Referring to FIGS. 14-16, tubular portion 210 includes a drivetube 228, a jaw closer 230, a jaw assembly 218 and an outer tube 220.Outer tube 220 is seated within an axial bore 224 of cylindrical tuberetainer 222 which is fixedly mounted in the distal end of body portion212. This retains the outer tube 220 in a fixed position.

[0065] Inner or drive tube 228 is received in longitudinal bore 226 ofouter tube 220 and is frictionally mounted at its proximal end withinaxial bore 285 of drive block 282 which is positioned in body portion212. Thus, drive tube 228 is reciprocated by drive block 282 in themanner described below. Also mounted within outer tube 220 is jaw closer230. Jaw closer 230 has a proximal mounting rod 236 seated within axialbore 229 of drive tube 228 such that head 231 abuts the distal edge. Thejaw closer 230 is moved by the drive tube 228 from a proximal positionas shown in FIG. 16 to a distal position as shown in FIG. 18 to move thejaws to the closed position. More specifically, jaw closer 230 has acamming surface 234 at its distal end 232 which engages the underside oflower jaw 250 (as viewed in FIG. 14) to force lower jaw 250 towardsupper jaw 270. This is described in more detail below.

[0066] Jaw assembly 218, mounted to outer tube 220 by mounting pin 278(or alternatively brazed into the outer tube), includes a movable jaw250 and a stationary jaw 270 which are hinged at the proximal end 251and are spaced apart thereafter to form a gap 253 therebetween. Movablejaw 250, as best shown in FIGS. 16 and 18, has a camming edge 252 on itslower surface (as viewed in FIG. 16) which cooperates with the cammingsurface 234 of the jaw closer 230. A pair of arms 257 at the distal endform a receiving recess 254 for mounting the suture securing element216. Stop surface 256 on arm 257 limits the travel of jaw 250 towardsjaw 270. Cutting blade 260, positioned proximally of arms 257, is alsocammed towards stationary jaw 270 by camming surface 234 and isconfigured to engage and cut the suture concomitantly with the crimpingof the suture securing member 216.

[0067] Stationary jaw 270 has an abutment surface 274 which cooperateswith stop surface 256 of movable jaw 250 to limit travel thereof.Backstop 272 facilitates cutting of the suture when contacted by cuttingblade 260.

[0068] Jaw assembly 218 has a conically shaped proximal end 219, bestshown in FIG. 21, to mount suture tube 320. This conical shapefacilitates threading of the suture through the instrument as describedbelow. Suture tube 320 extends through axial bore 229 of drive tube 228and through central bore 288 of body portion 212, exiting through a sideportion as shown in FIG. 15.

[0069] An end cap 276 is mounted at the distal end of the jaw assembly218 and has an opening to enable loading and removal of the suturesecuring member 216. The suture securing member 216, as shown in FIG. 17has a cylindrical tubular portion 240 dimensioned for reception inreceiving recess 254 of arms 257. Head 244 is designed to abut thesutured tissue. Examples of alternate configurations for the suturesecuring member are disclosed in pending U.S. application Ser. No.08/201,864, filed Feb. 24, 1994, the contents of which are incorporatedherein by reference.

[0070] Turning now to the body portion 212 of apparatus 200, and withreference to FIGS. 14 and 15, drive block 282, biased proximally byspring 297, is seated within central bore 288 and as mentioned above hasan opening 285 to frictionally receive the proximal end of drive tube228. Proximal of head portion 283 is a recessed area, defined by reduceddiameter rod portion 284, for mounting locking collar 286. Moreparticularly, spaced apart fingers 291 of locking collar 286 straddlerod portion 284 as best shown in FIG. 22. Locking collar 286 operativelyconnects the lever 214 and link 306 to the drive block 282.

[0071] Lever 214 is mounted at its distal end to body portion 212 vialever pin 314 extending through distal apertures 304 and throughopenings 246 in the body portion 212. Lever 214 is connected at itsproximal end to link 306 via link pin 312 extending through apertures308 and 302. The distal end of link 306 is seated in locking collar 286such that collar pin 316 extends through aperture 310 in link 306 andthrough apertures 293 in the locking collar 286. As shown, in theinitial position of FIG. 15, lever 214 extends at an angle to thelongitudinal axis of body portion 212. When the lever 214 is pivoted tothe closed position of FIG. 19 to actuate the instrument, it moves intorecess 280 (FIG. 14) in body portion 212 and buts planar surface 281 ofdrive block 282.

[0072] Body pins 290A and 290B extend through openings 212 a, 212 b inthe body portion 212 to engage slots 225 formed in tube retainer 222.This holds tube retainer 222 fixed with respect to body portion 212.

[0073] As can be illustrated, lever 214 is connected to the lockingcollar 286 via link 306. Locking collar 286, in turn, straddles driveblock 282 which mounts drive tube 228. Drive tube 228 mounts jaw closer230. Consequently, movement of lever 214 to its closed position slideslocking collar 286, drive block 282, drive tube 228, and jaw closer 230distally to cam the jaws to the closed position. Outer tube 220 and jawassembly 218 remain fixed during this movement as outer tube 220 ismounted to fixed tube retainer 222 and jaw assembly 218 is mounted tostationary outer tube 220.

[0074] In use, in the initial (prefired) position of FIG. 15, lever 214is positioned at an angle to the longitudinal axis of body portion 212,spaced from recess 280, such that locking collar 286 and drive tube 282are in the proximal position (biased by spring 297). Thus, drive tube228 and jaw closer 230 are also in the proximal position such thatcamming surface 234 of closer 230 is spaced from the cooperating cammingedge 252 of movable jaw 250 (see FIG. 16). When it is desired to crimpthe suture securing member 216 positioned in arms 257 between movablejaw 250 and stationary jaw 270, lever 214 is moved towards body portion212 and into receiving recess 280. This slides the locking collar 286and drive block 282 distally against the force of spring 297 to theposition shown in FIG. 19. This longitudinal translation of the driveblock 282 slides the drive tube 228 and jaw closer 230 distally to causethe camming surface 234 to engage camming edge 252 of movable jaw 250 toforce the movable jaw 250 towards stationary jaw 270 (see FIG. 20). Thiscrimps the suture securing member 216 between the jaws 250, 270. As themovable jaw 250 is moved to the closed position, cutting blade 260contacts and cuts the suture against the backstop 272 of stationary jaw270. When pressure on lever 214 released, lever 214 returns to its openposition and drive tube 228 returns to its proximal position under theforce of spring 297.

[0075]FIGS. 17 and 18 illustrate the suture securing member 216 beingmanually loaded through end cap 276 into the apparatus 200. As shown,the suture securing member 216 is seated within receiving recess 254between arms 257 of the movable jaw 250. It should be understood thatalternatively, apparatus 200 can be provided with the suture securingmember preloaded in the apparatus.

[0076] Referring now to FIGS. 23-29, a preferred method of dosing apuncture in a blood vessel is disclosed. FIG. 24 illustrates guide wire506 passing extracorporeally through tissue 504 and puncture 502 invessel 500. Vessel 500 is typically the femoral artery, wherein puncture502 was created to access the circulatory system to perform, forexample, an angioplasty or angiography procedure. External pressure(indicated by arrow X) can be applied to reduce or eliminate blood flowthrough puncture 502. As shown and described herein, the distal end ofguide wire 506 is directed towards the torso of the patient.

[0077] Turning to FIG. 25, cannula 508 and obturator assembly 509 havebeen inserted such that the distal end of the cannula 508 is disposedsubstantially adjacent puncture 502. Obturator assembly 509 preferablyincludes flexible outer sleeve 510 having a lumen through which passesflexible tubular member 512. Alternately, sleeve 510 and tubular member512 can be combined into one unit with two channels. Tubular member 512also has a lumen passing therethrough which is sized to receive guidewire 506. In use, guide wire 506 is used to direct the cannula andobturator assembly to puncture 502. The proximal end of obturatorassembly has valve assembly 516 having fittings 518 and 520 incommunication therewith. Guide wire 506 passes through fitting 520 whilefitting 518 is in fluid communication with outer sleeve 510. As bestseen in FIG. 25A, sleeve 510 has aspiration port 514 that is disposedwithin vessel 500 when the obturator assembly is placed in a desiredposition. Fluid communication between orifice 514 and fitting 518 allowsfor blood aspiration to positively indicate proper positioning ofcannula 508 and for the injection of fluids into vessel 500, if desired.

[0078] After cannula 508 has been properly placed, obturator assembly509 is slid off guide wire 506 and the previously described surgicalsuturing apparatus 10 is threaded over the guide wire by passing theguide wire through opening 39 in tongue 36 (see, for example, FIG. 5)and through instrument 10. The suturing instrument can then be directedthrough cannula 508. Tongue 36 at the distal end of apparatus 10 ispassed through puncture 502 such that vessel tissue adjacent thepuncture is disposed in window 15, between tongue 36 and face 46 ofapparatus 10. Lever 101 (not shown) can then be manipulated aspreviously described to draw a ferrule and suture through the vessel. Asshown, a preferred method is to first direct a suture through theinferior side of the puncture. The suturing device can then be rotatedto the other side of puncture 502, i.e., the superior side, and lever102 (not shown) can be manipulated to draw the second ferrule and suturethrough the vessel. After application of the suture, instrument 10 iswithdrawn from cannula 508, leaving suture 75 behind.

[0079] Turning to FIGS. 28-29, a. preferred method for tightening andsecuring suture 75 to close puncture 502 is illustrated. The loose endsof suture 75 are threaded through the distal end of a suture securingdevice, such as device 200 shown and previously described with respectto FIGS. 13-23. As shown in FIG. 29, device 200 with the suture passingtherethrough is introduced into cannula 508. The suture is pulled tight(FIGS. 18 and 20), and lever 214 of device 200 is actuated tosimultaneously crimp a securing member and cut suture 75. Device 200 andcannula 508 can then be removed and a topical bandage applied.

[0080]FIG. 30 illustrates a surgical kit 600 useful for dosing apuncture in a blood vessel. The kit preferably includes suturing device10, suture crimping device 200, cannula 508 and an obturator assemblyincluding two coaxial flexible tubular members 510, 512. The kitpackaging can be at least partially fabricated from thermoformed plastic602 fabricated from polyethylene fibers, (such as TYVEK* available fromDupont) to facilitate sterilization.

[0081] It will be understood that various modifications can be made tothe embodiments disclosed herein. Therefore, the above descriptionshould not be construed as limiting but merely as examples of preferredembodiments. Those skilled in the art will envision other modifications.

What is claimed is:
 1. A surgical apparatus for closing a wound, thesurgical apparatus comprising: a tongue member having a distal sectioninsertable into a wound; and a face opposing the distal section of thetongue member and separated from the distal section of the tongue memberby a gap, the face having an area large enough to impede furtherinsertion of the apparatus into the wound.
 2. The surgical apparatus ofclaim 1 wherein the tongue member includes a cross-sectional perimeterapproximately filling the wound for holding the wound substantiallyfully open in the gap.
 3. The surgical apparatus of claim 2 wherein across-sectional perimeter at the face is greater than thecross-sectional perimeter of the tongue.
 4. The surgical apparatus ofclaim 1 further comprising a body portion having first and second leverspivotally secured to the body portion.
 5. The surgical apparatus ofclaim 4 further comprising an elongate body assembly connecting the bodyportion to the tongue member, and further comprising first and secondelongate needles positioned at least partially within the elongate bodyassembly, said first needle being longitudinally movable by said firstlever and said second needle being longitudinally movable by said secondlever.
 6. The surgical apparatus of claim 5 wherein the levers arespaced apart less than 180 degrees from each other.
 7. The surgicalapparatus of claim 5 wherein the levers are not diametricallypositioned.
 8. The surgical apparatus of claim 5 wherein the first andsecond elongate needles are eccentrically positioned within the elongatebody assembly.
 9. The surgical apparatus of claim 4 wherein the firstlever is a first color to indicate its connection with the first needle,and the second lever is a second color, different than the first color,to indicate its connection with the second needle.
 10. The surgicalapparatus of claim 4 wherein the first and second levers are mounted toa distal end of the body portion.
 11. The surgical apparatus of claim 1further comprising a sleeve holder positioned within the distal sectionof the tongue member, the sleeve holder including first and secondsleeves disposed within the sleeve holder, said first and second sleevesbeing joined by a length of suture material.
 12. The surgical apparatusof claim 1 further comprising a guide wire tube disposed through saidbody portion and said elongate body assembly, a distal end of the guidewire tube being disposed adjacent a distal opening of the tongue member.13. The surgical apparatus of claim 12 wherein the guide wire tubeincludes an opening spaced proximally the distal end thereof.
 14. Aneedle and ferrule configuration comprising: a needle having a shaft,the shaft having a shaft outer diameter, the needle further having atip, the tip having a pointed distal end and an intermediate sectionpositioned between the pointed distal end and the shaft, theintermediate section having a smaller outer diameter than the shaftouter diameter; and a ferrule having a proximal section sized to snuglyreceive the intermediate section of the needle, the proximal sectionhaving an outer diameter smaller than an outer diameter of the shaft ofthe needle.
 15. The needle and ferrule configuration of claim 14 furthercomprising a shoulder between the intermediate section and the shaft ofthe needle, the shoulder providing a transition from the shaft to theintermediate section.
 16. The needle and ferrule configuration of claim14 comprising a shoulder between the proximal section and a distalsection of the ferrule, wherein the distal section of the ferrule has asmaller outer diameter than the proximal section of the ferrule.
 17. Theneedle and ferrule configuration of claim 14 wherein the pointed distalend of the tip of the needle is conically shaped.
 18. The needle andferrule configuration of claim 14 wherein a strand of suture material isattached to a distal section of the ferrule.
 19. A surgical apparatuscomprising: a body portion having a distal end and a proximal end; atubular portion having a distal end and a proximal end, the proximal endof the tubular portion attached to the distal end of the body portion;and, a lever having a distal end and a proximal end, the distal end ofthe lever operatively coupled to the distal end of the body portion. 20.The surgical apparatus of claim 19 wherein the body portion includes alongitudinal axis and the lever includes a longitudinal axis, andfurther wherein the longitudinal axis of the lever is parallel to thelongitudinal axis of the body portion in a closed position of the lever.21. The surgical apparatus of claim 20 wherein the lever is actuable toa position where the longitudinal axis of the lever is askew from thelongitudinal axis of the body portion.
 22. The surgical apparatus ofclaim 19 wherein the lever is pivotally mounted to the body portion. 23.The surgical apparatus of claim 22 further comprising a link connectedat a first end to the lever and at a second end to a slidable memberwithin the body portion.
 24. The surgical apparatus of claim 23 whereinmovement of the proximal end of the lever towards the proximal end ofthe body portion forces the slidable member to move towards the distalend of the body portion.
 25. The surgical apparatus of claim 24 furthercomprising a drive block, wherein the slidable member cooperates withthe drive block to move the drive block correspondingly with theslidable member.
 26. The surgical apparatus of claim 25 wherein theslidable member is a locking collar which surrounds a reduced diameterportion of the drive block.
 27. The surgical apparatus of claim 25wherein the drive block is biased proximally by a spring.
 28. Thesurgical apparatus of claim 25 wherein the drive block includes alongitudinal opening for frictionally receiving a proximal end of adrive tube.
 29. The surgical apparatus of claim 24 wherein the proximalend of the lever is biased away from the proximal end of the bodyportion.
 30. The surgical apparatus of claim 23 wherein movement of theproximal end of the lever away from the proximal end of the body portionforces the slidable member to move towards the distal end of the bodyportion.
 31. The surgical apparatus of claim 30 wherein the slidablemember is a needle driver.
 32. The surgical apparatus of claim 31further comprising a needle in the tubular portion, the needle movablein response to movement of the needle driver.
 33. The surgical apparatusof claim 31 wherein the lever is a first lever, the link is a firstlink, and the needle driver is a first needle driver, the surgicalapparatus further comprising a second lever having a proximal end and adistal end, the distal end of the second lever operatively coupled tothe distal end of the body portion, a second link connected at a firstend to the second lever and at a second end to a second needle driverwithin the body portion.
 34. The surgical apparatus of claim 33 whereinthe second needle driver is positioned proximal to the first needledriver.
 35. The surgical apparatus of claim 34 wherein first needledriver receives a first needle, and the first needle driver has alongitudinal opening dimensioned to allow a second needle to passthrough the first needle driver freely to the second needle driver. 36.The surgical apparatus of claim 35 wherein the second needle driverreceives the second needle.
 37. The surgical apparatus of claim 36wherein the second needle driver includes an opening dimensioned tofrictionally receive the second needle, the opening for receiving thesecond needle being smaller than the longitudinal opening in the firstneedle driver for passing the second needle.
 38. The surgical apparatusof claim 34 wherein the first needle driver includes anotherlongitudinal opening dimensioned to frictionally receive the firstneedle, wherein the longitudinal opening receiving the first needle issmaller than the longitudinal opening for passing the second needle. 39.The surgical apparatus of claim 23 wherein the slidable member includesa tab with a hole, the second end of the lever surrounding the tab andconnected to the tab via a link pin inserted through the hole andthrough the second end of the lever.
 40. The surgical apparatus of claim19 wherein the lever has a generally U-shaped cross-section with a flatsurface of the lever lying substantially flush with the body portion ina closed position of the lever.
 41. The surgical apparatus of claim 19further comprising an end cap positioned on the proximal end of the bodyportion, the end cap having a recess adjacent the lever, sized forfacilitating actuation of the proximal end of the lever.
 42. Thesurgical apparatus of claim 19 wherein the lever is a first lever, thesurgical apparatus further comprising a second lever having a proximalend and a distal end, the distal end of the second lever operativelycoupled to the distal end of the body portion.
 43. The surgicalapparatus of claim 42 wherein the second lever is angularly displaced onthe body portion from the first lever.
 44. The surgical apparatus ofclaim 43 wherein the second lever is placed less than 180 degrees fromthe first lever.
 45. The surgical apparatus of claim 42 wherein thefirst lever includes a first color and the second lever includes asecond color, different than the first color.
 46. A tip for a surgicalapparatus, the tip having a longitudinal axis, a distal end, and aproximal end, the tip further comprising: a window for receiving tissue;a first wall at a proximal end of the window, the first wall disposed atan angle to the longitudinal axis, the angle selected to impedeinsertion of the tip into a wound; and, a second wall disposed at anangle to the longitudinal axis at a distal end of the window.
 47. Thetip of claim 46 wherein the second wall is disposed at an approximately90 degree angle to the longitudinal axis.
 48. The tip of claim 46wherein the distal end of the tip is tapered to a blunt surface.
 49. Thetip of claim 46 further comprising a ferrule holder, the ferrule holderincluding the second wall.
 50. The tip of claim 49 wherein the ferruleholder includes a pair of recesses for receiving ferrules.
 51. The tipof claim 49 further comprising a tongue extending between the first andsecond walls, wherein the ferrule holder includes projections receivablewithin grooves of the tongue for retaining the ferrule holder on thetongue.
 52. The tip of claim 51 wherein the tongue includes a lip whichwraps around a distal end of the ferrule holder for further retainingthe ferrule holder on the tongue.
 53. The tip of claim 46 furthercomprising a tongue, a base of the tongue forming a bottom portion ofthe window.
 54. The tip of claim 53 wherein a distance from the firstwall to the second wall at a bottom portion of the window is less than adistance from the first wall to the second wall at a top portion of thewindow.
 55. The tip of claim 53 wherein a proximal end of the tongueincludes a T-shaped extension.
 56. The tip of claim 55 furthercomprising a face, the face including the first wall, the facepositioned on a proximal portion of the tongue and distally of theT-shaped extension.
 57. The tip of claim 56 wherein the face is retainedon the tongue by a snap-fit connection.
 58. The tip of claim 53 whereinthe tongue includes a longitudinal opening having a proximal end and adistal end, the distal end of the longitudinal opening including an exitopening positioned proximally of the distal end of the tip.
 59. The tipof claim 46 further comprising a face, the face including the firstwall.
 60. The tip of claim 59 wherein the face includes a pair oflongitudinal openings substantially parallel with the longitudinal axisof the tip.
 61. The tip of claim 60 further comprising a ferrule holder,the ferrule holder including the second wall and a pair of recesses forreceiving ferrules, the pair of recesses longitudinally aligned with thepair of longitudinal openings in the face.
 62. The tip of claim 61wherein the pair of recesses for receiving ferrules further receivesutures.
 63. The tip of claim 61 further comprising a pair of ferrulesreceived within the pair of recesses, proximal ends of the ferrulesfacing the window, and distal ends of the ferrules connected to lengthsof suture material.
 64. A tip for a surgical apparatus, the tip having adistal end, a proximal end, and a longitudinal axis, the tip furthercomprising: a jaw assembly having an upper jaw and a lower jaw, aproximal end of the upper jaw connected to a proximal end of the lowerjaw; and, a jaw closer longitudinally movable relative to the jawassembly to move a distal end of the lower jaw towards a distal end ofthe upper jaw when the jaw closer is moved towards the distal end of thetip.
 65. The tip of claim 64 wherein the jaw closer is passable beneaththe lower jaw.
 66. The tip of claim 64 wherein the distal end of thelower jaw receives a suture securing element, wherein, when distal endsof the upper and lower jaws are moved towards each other, the suturesecuring element is crimped between the upper jaw and lower jaw.
 67. Thetip of claim 66 wherein the lower jaw includes a pair of arms forreceiving the suture securing element.
 68. The tip of claim 67 whereinthe lower jaw further includes a cutting blade proximal the pair ofarms.
 69. The tip of claim 66 comprising a cutting blade.
 70. The tip ofclaim 69 wherein the upper jaw includes a backstop for abutting with thecutting blade.
 71. The tip of claim 64 wherein a distal end of the jawcloser includes a camming surface for abutting a camming edge of one ofthe upper and lower jaws.
 72. The tip of claim 64 further comprising alongitudinal opening for receiving a suture securing element.
 73. Thetip of claim 72 further comprising an end cap at the distal end of thetip, the end cap including the longitudinal opening.
 74. A method ofapproximating tissue sections with a surgical tip, the surgical tiphaving a distal end, a proximal end, and a longitudinal axis, the methodcomprising: inserting a tapered distal end of the tip between the tissuesections; disposing a first tissue section within a gap in the tip;placing the first tissue section against a wall of the gap; directing asuture through the gap and the first tissue section; moving the surgicaltip; disposing a second tissue section within the gap; placing thesecond tissue section against the wall; directing a suture through thegap and the second tissue section; and removing the surgical tip fromthe tissue sections.
 75. The method of claim 74 wherein moving thesurgical tip comprises rotating the surgical tip.
 76. The method ofclaim 74 further comprising threading loose ends of the suture through adistal end of a suture securing device and crimping a securing memberupon the suture.
 77. The method of claim 76 further comprising pullingthe suture tight prior to crimping the securing member upon the suture.78. The method of claim 76 further comprising cutting the suture whilecrimping the securing member upon the suture.
 79. The method of claim 78further comprising moving a single lever one time for cutting the sutureand crimping the securing member.
 80. An obturator assembly and cannulafor locating a suturing instrument in a vessel, the obturator assemblyand cannula comprising: a flexible tubular member having a firstlongitudinal bore for receiving a guide wire; a flexible outer sleevehaving a second longituidinal bore encircling the flexible tubularmember, the outer sleeve having an aspiration port in a side of thesecond longitudinal bore disposed between a proximal and a distal endthereof; and, a cannula having a third longitudinal bore sized forsurrounding the flexible outer sleeve.
 81. The obturator assembly andcannula of claim 80 wherein the turbular member comprises a distal endthat is more flexible than a proximal end.
 82. The obturator assemblyand cannula of claim 80 wherein the flexible tubular member is longerthan the outer sleeve.
 83. The obturator assembly and cannula of claim80 wherein a proximal end of the assembly has a valve assembly withfittings.
 84. The obturator assembly and cannula of claim 83 wherein onefitting in the valve assembly is in fluid communication with the secondlongitudinal bore allowing blood aspiration to positively indicateproper positioning of the surrounding cannula.
 85. A single use kit forclosing an opening in a vessel comprising: a surgical apparatus forsuturing the opening; and, a combination crimper and cutter for securinga suture and cutting its ends.
 86. The single use kit of claim 85further comprising a cannula.
 87. The single use kit of claim 85 whereinthe surgical apparatus comprises a tip having a longitudinal axis, adistal end, and a proximal end, the tip further comprising: a gap forreceiving tissue; a first wall at a proximal end of the gap, the firstwall having a pair of longitudinal openings for receiving needles; and,a second wall at a distal end of the window, the second wall having apair of ferrule recesses for receiving ferrules.
 88. The single use kitof claim 85 wherein the combination crimper and cutter comprises a tiphaving a distal end, a proximal end, and a longitudinal axis, the tipfurther comprising: a jaw assembly having an upper jaw and a lower jaw,a proximal end of the upper jaw connected to a proximal end of the lowerjaw; and, a jaw closer longitudinally movable relative to the jawassembly to move a distal end of the lower jaw towards a distal end ofthe upper jaw when the jaw closer is moved towards the distal end of thetip.